Jointly issued by four departments: 100 kinds of medicine in short supply will be produced centrally

Source: IGU February 2, 2018 Today (February 1), the Ministry of industry and information technology, together with the health and Family Planning Commission, the national development and Reform Commission and the food and drug administration, issued the notice on organizing the construction of the centralized production base for small varieties of drugs (drugs in short supply) (hereinafter referred to as the notice) The notice made it clear that the construction of the centralized production base for small varieties of drugs, small market consumption and insufficient production power of enterprises would be organized According to the notice, small product drugs (short drugs) refer to drugs that are clinically necessary, small in dosage, unstable in market supply and prone to clinical shortage At the same time, according to the notice, in practical work, in combination with the demand for drug supply guarantee and the national layout of the centralized production base, about five enterprises will be selected and identified to build the centralized production base of small drug varieties By coordinating and solving the problems such as small drug number transfer, entrusted production, centralized procurement, supply and demand docking, supporting enterprises to centralize the upstream and downstream high-quality resources of the industrial chain, promoting the implementation of the target task of the construction of the centralized production base, by 2020, the centralized production and stable supply of 100 small drug varieties will be basically achieved As for the enterprise standard of building a centralized production base of small product and drug, the notice requires that it should be one of the top 100 enterprises in the pharmaceutical industry, with more than 20 small product and drug production number and supporting production capacity of API, meet the requirements of full dosage form of drugs (vaccines) in production, strong quality control ability and wide distribution network coverage, and be able to fulfill the responsibility of stable production and supply In addition, according to the notice, the Ministry of industry and information technology will sign a letter of responsibility for the construction of the centralized production base of small drugs with enterprises to clarify the construction cycle, responsibility objectives, guarantee varieties and the responsibilities and obligations of the stable production and supply of drugs The Ministry of industry and information technology, together with relevant departments, will strengthen the supervision and evaluation of the construction of the centralized production base Enterprises that meet the requirements shall be disqualified Attachment: Notice on organizing the construction of the centralized production base of small drugs (short of drugs) issued by the Ministry of industry and information technology of the people's Republic of China [2018] No 21 of all provinces, autonomous regions, municipalities directly under the central government, the competent department of industry and information technology of Xinjiang production and Construction Corps, the health and Family Planning Commission (Health Bureau), the development and Reform Commission, and the food and Drug Administration: In order to implement the guidelines for the development planning of the pharmaceutical industry (mijlg [2016] No 350) and the implementation opinions on the reform and improvement of the supply guarantee mechanism of short drugs (gwyzf [2017] No 37), the Ministry of industry and information technology, the state health and Family Planning Commission, the Ministry of industry and information technology, the state health and Family Planning Commission, the Ministry of industry and information technology, the Ministry of industry and information technology, the state health and Family Planning Commission, the Ministry of industry and information technology of the people's Republic of China, the Ministry of industry and information The national development and Reform Commission and the State Food and Drug Administration jointly organized the construction of the centralized production base of small drug varieties The relevant matters are hereby notified as follows: 1 The working ideas and objectives adhere to the principles of market leading, government guidance, innovation mechanism and classified implementation, fully mobilize the enthusiasm and initiative of enterprises, integrate and utilize the existing industrial resources, give play to the effect of centralized production scale, and ensure the continuous and stable supply of small products and drugs In combination with the demand for drug supply guarantee and the national layout of the centralized production base, about 5 enterprises (groups, the same below) are selected and identified to build the centralized production base for small drug varieties By coordinating and solving the problems of small product drug number transfer, entrusted production, centralized procurement, supply and demand docking, supporting enterprises to concentrate the upstream and downstream high-quality resources of the industrial chain, promoting the implementation of the target task of the construction of the centralized production base, and by 2020, realizing the centralized production and stable supply of 100 small product drugs 2、 The selection of centralized production base and identification of small product drugs (drugs in short supply) refers to drugs that are clinically necessary, small in dosage, unstable in market supply and prone to clinical shortage （1） Recognition conditions The enterprises to build the centralized production base of small product and drug should be the top 100 enterprises in the pharmaceutical industry, with more than 20 small product and drug production number and supporting production capacity of API, which meet the requirements of full dosage form of drugs (vaccines) in production, strong quality control ability and wide distribution network coverage, and can fulfill the responsibility of stable production and supply （2） Identification procedure Qualified pharmaceutical manufacturers shall apply to the competent departments of industry and information technology of all provinces (autonomous regions and municipalities directly under the central government) After consultation with the departments of health and family planning, development and reform, food and drug supervision, the competent departments of industry and information technology shall recommend the application to the Ministry of industry and information technology The Ministry of industry and information technology, together with relevant departments, shall organize experts to review and study and determine the centralized production base of small drugs （3） Responsibility to protect The Ministry of industry and information technology has signed a letter of responsibility for the construction of the centralized production base of small drug varieties with the enterprise to clarify the construction cycle, responsibility objectives, guarantee varieties and the responsibilities and obligations for the stable production and supply of drugs undertaken by the centralized production base The Ministry of industry and information technology, together with relevant departments, strengthened the supervision and evaluation of the construction of the centralized production base, and cancelled the corresponding qualifications of enterprises that did not meet the requirements 3、 Strengthen the policy support of centralized production base (1) support enterprises to strengthen the construction of centralized production base The Ministry of industry and information technology and the national development and Reform Commission support the identified enterprises to carry out production technology transformation, coordinate and promote the enterprises to carry out the consistency evaluation of the quality and efficacy of small drug varieties, support the enterprises to centralize the upstream and downstream resources of APIs and preparations, establish the pharmaceutical production and supply guarantee alliance, and realize the stable production and supply of small drug varieties （2） Priority shall be given to the review and approval of small drugs The food and drug regulatory authorities shall give priority to the review and approval of the registration application of small drug varieties and APIs that are urgently needed in clinical practice and short of market in the centralized production base, as well as the transfer of production technology and entrusted production and processing of small drug varieties and APIs that are centrally produced and achieve scale effect （3） Implement the centralized purchase of small drugs The national health and Family Planning Commission further optimizes the purchase mechanism of small drug varieties, guides all regions to purchase the small drug varieties produced in the centralized production base on the Internet according to the regulations; for the small drug varieties whose market mechanism fails to form a reasonable price, the health and family planning administrative department, together with the relevant departments, conducts market matching, determines the reasonable purchase price, and ensures the continuous and stable supply （4） Strengthen the connection of supply and demand information of small product and drug The national health and Family Planning Commission and the Ministry of industry and information technology, through the construction of a multi-source information collection and supply business collaborative application platform for drugs in short supply, have a dynamic grasp of the production and inventory of small drug varieties in the centralized production base, strengthen the connection of supply and demand information of small drug varieties in combination with the use needs of medical and health institutions, carry out monitoring, early warning, analysis and judgment in a timely manner to avoid poor communication of supply and demand information There is a shortage of supply All units shall actively organize and carry out the construction of the centralized production base of small product and drug For the enterprises with basic conditions in the region, strengthen guidance, cultivation and policy support to improve the ability of drug supply guarantee; for the enterprises meeting the identified conditions, the local competent departments of industry and information technology encourage the enterprises to apply and recommend the application to the Ministry of industry and information technology (Department of consumer goods industry) according to the procedures Ministry of industry and information technology, health and Family Planning Commission, development and Reform Commission, food and drug administration, January 19, 2018